Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

Solid Tumor Clinical Trial

— BIP  

Official title:

Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02534649
• Other study ID #: IB2015-09
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2029

Study information

• Verified date: February 2023
• Source: Institut Bergonié
• Contact: Antoine ITALIANO, MD, PhD
• Email: a.italiano[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.

In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.

Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

Description:

The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.

The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2029
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years,

2. Histology: solid malignant tumor or hematological malignancy,

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7. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),

8. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

1. Deleted MSA9

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9. Individuals deprived of liberty or placed under guardianship

10. Pregnant or breast feeding women,

11. Previous enrolment in the present study.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Solid Tumor

Intervention

Procedure:
• Newly obtained biopsy and Blood samples collection
For each patient: Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient. Patients for whom no molecular aberration has been identified will be treated at the discretion of the investigator and followed until death or study termination whichever occurs first. All the patients carrying a molecular aberration will be proposed to enter in a clinical trial depending on the possibility of inclusion at the time of molecular report.

Locations

Country	Name	City	State
France	Centre Hospitalier de la Côte Basque	Bayonne
France	Clinique Tivoli-Ducos	Bordeaux
France	Institut Bergonie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Hospitalier de Pau	Pau
France	Clinique Marzet	Pau
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients presenting at least one genomic alteration	The proportion of patients with advanced cancer presenting at least one genomic alteration will be described in the NGS population and reported using the proportion. The 95% two-sided confidence limits (95%CI) will be provided for the calculated rate (binomial law).	1 month
Secondary	- Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)	Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies. For a patient with NGS results available, utilization of molecular profiling information is defined as : Inclusion in a clinical trial assessing a drug matched with the genetic profile; Treatment with an approved drug matched with the genetic profile	Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months
Secondary	Rate of molecular screening failure	Rate of molecular screening failure. Molecular screening failure is defined as the impossibility to provide genetic profiling because as a result of inadequate tissue or DNA quantity or quality.	Molecular screening failure will be assessed at 1 month
Secondary	Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.	Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.	Safety will be assessed 1 month after biopsy